Universal reference book for medicines
Product name: ULTRAPROCT (ULTRAPROCT)

Active substance: cinchocaine, fluocortolone

Type: The drug with anti-inflammatory and local anesthetic action for topical application in proctology

Manufacturer: INTENDIS (Germany) manufactured by INTENDIS MANUFACTURING (Italy)
Composition, form of production and packaging
Ointment rectal
colorless or slightly yellowish color, translucent.

1 g

fluorocortolone hexonate 945 μg

fluocortolone pivalate 918 μg

cinchocaine hydrochloride 5 mg

Excipients: 2-octyldodecanol, castor oil, hydrogenated castor oil, macrogol-400-monoricinoleate (polyethylene glycol-400-monoricinoleate), lemon-pink perfume PH No. 65803.

10 g - aluminum tubes (1) complete with a special plastic tip - packs of cardboard.

Suppositories rectal white or yellowish white, with a smooth surface.

1 supp.

fluorocortolone hexonate 630 μg

fluocortolone pivalate 612 μg

cinchocaine hydrochloride 1 mg

Excipients: solid fat (Witepsol W35) - 1797.758 mg.

5 pieces.
- Strips aluminum (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combination drug for topical application in proctology.
Has anti-inflammatory, antipruritic, anti-allergic, local anesthetic effect.
Fluocortolone , which is part of the drug in two forms, provides a rapid onset of action and a longer duration.
With topical application it prevents the accumulation of neutrophils, which leads to a decrease in inflammatory exudate and production of lymphokines, inhibition of migration of macrophages, reduction of infiltration and granulation.
Tsinghokain is a local anesthetic.
Anesthesia is achieved by suppressing the formation and carrying out of nerve impulses along afferent nerve fibers by depolarizing the sodium channels.
PHARMACOKINETICS

Suction

Fluorocortolone pivalate and fluocortolone hexanoate, having different lipophilicity and molecular weight, diffuse at different rates, which provides a rapid onset of action and a longer duration.

Metabolism

Fluorocortolone is hydrolyzed by esterases, enzymes of the inflammatory focus, with the formation of fluocortolone, 11-ketofluocortolone and trimethylacetic acid.

Excretion

T 1/2 of fluocortolone and its metabolites after rectal administration is 1.3 and 4 hours, respectively.

Fluocortolone is excreted as metabolites, mainly by the kidneys.

INDICATIONS

- hemorrhoids;

- superficial anal fissures;

- proctitis.

DOSING MODE

Before using the Ultraprotect, anus hygiene should be performed.
It is recommended to use Ultraprotect after defecation.
Usually there is a rapid improvement, however, in order to avoid relapse, the treatment should be continued for at least 1 more week, but with a lower frequency of application (ointment-1 time / day or 1 suppository every other day), even with complete disappearance of symptoms.
Duration of treatment, if possible, should not exceed 4 weeks.
Ointment , as a rule, apply 2 times / day;
the first day for the speedy alleviation of symptoms - up to 4 times / day.
A small amount of ointment (about the size of a pea) should be spread around the anus and inserted into the anus.
Ointment is applied with the tip of the finger to overcome the resistance of the sphincter. Before the introduction of the ointment into the rectum on the tube, it is necessary to screw the attached tip. Then, lightly pressing the tube, squeeze a small amount of ointment into the rectum.
Suppositories are injected deep into the rectum, usually 1 pc.
daily. In severe disease, on the first day, 1 suppository is administered 2-3 times / day.
In the presence of highly inflamed, painful gerorrhalic nodes, it is recommended to begin treatment with ointment.
The protruding hemorrhoids should be densely lubricated with ointment and gently press the finger back.
If, under the influence of heat, the candles are softened, they should be placed in cold water without removing the packaging, then they will again assume their former form.

SIDE EFFECT

Possible: burning, itching, dry skin.
With prolonged use (more than 4 weeks) skin atrophy, telangiectasia, hypopigmentation are possible.
Rarely: allergic reactions.

CONTRAINDICATIONS

- manifestations of tuberculosis, syphilis in the application of the drug;

- manifestations of viral diseases (for example, chickenpox, response to vaccination) in the area of ​​application of the drug;

- I trimester of pregnancy;

- Hypersensitivity to the components of the drug.

Use in children and adolescents is not recommended, due to the lack of clinical data.

PREGNANCY AND LACTATION

A number of epidemiological studies suggest a possible increased risk of development of the wolf mouth in newborns whose mothers received SCS in the first trimester of pregnancy.
Data on the use of local GCS during pregnancy is not accumulated enough, but in this case the likelihood of adverse effects is very low due to the minimal availability of GCS in topical application.
Ultraproject should be administered with caution in the II and III trimesters of pregnancy.
When appointing pregnant or lactating women, it is necessary to compare the expected benefit of treatment for the mother with the possible risk to the fetus and the baby.
When prescribing the Ultraprotection during pregnancy and during lactation, the drug should be used for a short time.

APPLICATION FOR CHILDREN

Use in children and adolescents is not recommended due to the lack of clinical data.

SPECIAL INSTRUCTIONS

If fungal infections are present, additional antifungal therapy is necessary.

Avoid getting inside or eye contact.

After application, it is recommended to wash your hands thoroughly.

Impact on the ability to drive vehicles and manage mechanisms

Not found.

OVERDOSE

According to the results of acute toxicity studies of esters of fluocortolone and cinchocaine hydrochloride, acute intoxication is unlikely to occur with a single rectal or perianal administration of the Ultraproject even with an occasional overdose.

In case of accidental ingestion of the drug inside (for example, if several grams of ointment or several suppositories are swallowed), it is possible to develop predominantly the symptoms of the side effect of cinchocaine hydrochloride of a somatic nature, which, depending on the dose, may manifest as severe cardiovascular disorders cardiac arrest), and in the form of violations from the CNS (convulsions, respiratory depression, right up to the stopping of breathing).

DRUG INTERACTION

In the conduct of clinical trials and the use of the drug in medical practice, no interaction or incompatibility with other drugs has been identified.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Ointment should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 4 years.
Rectal suppositories should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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